Member Info for Burble

Https://www.pmlive.com/pharma_news/bristol_myers_squibbs_opdivo_approved_by_ec_for_expanded_melanoma_use_1496698

Wonder what the impact of this will be if we get positive SCOPE trial results.

May not be beyond the realms of possibility. We know there is a shift in gears in the UK when it comes to preparing for the next pandemic - whatever that may be.

https://news.sky.com/story/amp/uk-scientists-begin-work-on-defending-against-new-pandemic-caused-by-disease-x-12934956

Obviously putting the governments involvement/interest with moderna and mRNA vaccines more broadly aside, there is an understanding that storage, supply chains, mass production and ease of delivery are high up the list of wants for any new vaccine.

What’s also of interest is the interest in developing something better than mRNA lipid nanoparticle delivery - because the UK supply chain for this isn’t fantastic and there are complexities around patents and IP.

SCLPs Immunobody vaccine has a lot of these ticked off, long patent life and vaccines which have been demonstrated multiple times in the clinic as being safe to use and effective.

IMHO it may not be as crazy an idea as we may imagine.

'Why don't Scancell at the very least just give the RNS descriptive titles?'

This I believe is something that they fail miserably to do. If you look through a load of the historic RNS titles:

Modi-1 trial open for expansion in CPI combination

Scancell to present Modi-1 data at ASCO

ModiFY phase 1/2 poster presentation at AACR2023

Encouraging early efficiency data from ModiFY trial

Positive response in COVIDITY trial

Licenses vaccitech technology to advance Modi-2

First patient dosed in expansion phase of ModiFY

Phase 2 SCOPE trial of SCIB1 vaccine expanded

First patient dosed in SCIB1 phase 2 trial

First subject dosed in COVIDITY clinical trial

Scancell selects PharmaJet’s Needle-free systems

COVIDITY trial planned in South Africa and UK

Now just slightly reword them and see what would happen if investors were glancing down then daily 0700 RNS list.

Modi-1 cancer vaccine trial open for expansion in checkpoint inhibitor combination

Scancell to present Modi-1 cancer vaccine data at ASCO

ModiFY cancer vaccine phase 1/2 poster presentation at AACR2023

Encouraging early efficiency data from ModiFY cancer vaccine trial

Positive response in COVIDITY covid-19 T-cell vaccine trial

Licenses vaccitech technology to advance Modi-2 cancer vaccine

First patient dosed in expansion phase of ModiFY cancer vaccine trial

Phase 2 SCOPE trial of SCIB1 melanoma cancer vaccine expanded

First patient dosed in SCIB1 phase 2 melanoma cancer vaccine trial

First subject dosed in COVIDITY Covid-19 T-cell vaccine clinical trial

Scancell selects PharmaJet’s Needle-free systems for delivery of cancer vaccines

COVIDITY covid-19 T-cell vaccine trial planned in South Africa and UK

These additions are not changing the message at all, but would go some way to drumming up additional interest and support, both from PIs and others.

An exciting title too - 'Clinical update on the DC targeting melanoma vaccine, SCIB1 and the Modi-1 vaccine targeting citrullination'

I wonder when the cut off date for the titles for her talk was.

An interesting point from Andrew Forrest regarding the UK position on climate action.

https://twitter.com/bloomberguk/status/1685972812299714560?s=46&t=A6vOxblM5AgE5_ReawinRA

What impact would that have if he pulled investment in GGP? Would the ASX cross-listing insulate us from some of this?

I will be really interested to see what the AGM data this year looks like. By then we should have nice lengths of time from the early cohorts, further data from the monotherapy cohorts and some nice data coming in from the CPI cohorts. In turn I hope to see some histology images of H&E stained slides from pre- and post-resected tumour. It hopefully will be very exciting!

‘Modi-1 treatment were well tolerated in Cohort 4 with no safety concerns. Encouragingly, the first patient to be assessed has shown a tumour regression at their first radiological assessment at 8 weeks. The remaining patients have not yet been assessed radiologically.’

Will be interesting to see if this is replicated across the CPI cohorts.

Listed as a sell on here.

Please note that this article posted in the thread below is from 2022.

At the time Merck were wanting to purchase Seagen, but that fell through.

Pfizer has subsequently offered to buy Seagen in March of this year, but I'm unsure whether that has been approved by the Federal and Trade Commission as they have asked for further information on this. https://www.fiercepharma.com/pharma/ftc-asks-pfizer-seagen-more-information-proposed-43b-merger

Or if one of these companies made a bid for the entire platform, there could be a bidding war between other evaluators.

Great points JB1. It will be interesting to see the next accounts to see whether this revenue data has come in.

Crumbs where you say 'pity Modi 1s potency in that Ovarian cohort is not by itself game changer' - remember that this is a phase 1 trial. The data that comes from this, will help understand what Modi-1 is doing in different cohorts. You will see as we progress through further trials that the inclusion/exclusion criteria may be adjusted accordingly.

I would say given the aggressive nature of ovarian cancer and the fact many patients relapse quickly. A 44% disease control rate in ovarian cancer patients is quite the opposite - these are patients who have limited options left, have failed front line therapy and are on a steep glide path sadly. So a 44% disease response rate may be a game changer for these patients if this is reflected in larger studies.

Just remember, this is a small cohort of patients so far, larger studies will give a truer picture of what is happening.

So 20-23rd September are the dates to watch out for!

If not, then means I can use this months pay cheque for a top up!

Ciaskin. Unsure, wouldn’t surprise me if it’s Genmab. BioNTec seem to be focussing on mRNA tech. But I can see you can read it two ways - existing collaboration vs potential new collaboration.

DarkPrince - I would say quite the opposite!

Take a look at the 3 year results data from the Phase 1 (KEYNOTE-001) trial for Keytruda. ‘ At 36 months, investigator-assessed objective response according to immune-related response criteria was achieved for 41 of 101 treatment naive patients (41% [95% CI 30·9–50·8]; median duration of response was 16·7 months [95% CI 12·6–not reached]) and 102 of 449 previously treated patients (23% [18·9–26·9]; 33·3 ([22·5–not reached]).’

Our patients have exhausted treatment options.

Keytruda made it through Ph1-3 trials and is currently making $21bn in 2022 sales.

(Reference https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30500-9/fulltext#seccestitle150)

‘The platform has generated revenues and the antibodies continue to yield compelling results which have led to a new 6-month evaluation by a leading Biotech company. Additional in-house data has illustrated the potential of our antibodies as chimeric antigen receptor T cell (CART) therapies providing the data for a deal with a cell therapy company.’

I wonder whether this is a hint that a deal should cross the line for this before H2 2024

Something I have sensed from my current work, this government believes that mRNA (and oligonucleotides in general) are the next big thing. They’re investing heavily, pushing for mRNA tech. I and many others worry that there’s a high chance they’re putting their eggs in a single basket. The industry knows that personalised treatments, whilst effective, are going to costly to produce and have other pain points in supply chains and manufacturing. There is also a huge issue currently with delivery technologies for mRNA technology, with lots of legal wrangling over the lipid nano particle technology used to deliver it.

An off the shelf vaccine which doesn’t use the large pharma’s LNP IP has a real disruptive potential and wouldn’t surprise me if one of two scenarios happens. Either quietly purchased on the side by a company before others get proper wind of it. Or a bidding war between big pharma.

HexaBody® technology platform - ( Burble has Glymab platform anything to do with this ?)

Not specifically, but hexabody technology could be applied to any antibody. So the antibody that genmab licensed could have hexabody technology applied to it. In a very similar way to how our own Avidimab could be applied to any antibody. It is a platform technology with broad applications.

Basically it seems it is a single amino acid change within the Fc region of the antibody (similar to our finding with Avidimab). This causes clustering of six bound antibodies (hexamerisation) to occur on the surface of the cell. Once hexamerisation occurs, this results in improvements in downstream effects but also complement-dependent cytotoxicity. Basically, as a technology platform it can convert antibodies into potent cytotoxic antibodies.

As this is a platform technology and genmab have other Fc engineered antibodies, it wouldn't surprise me in the slightest if the were one of the first to license or purchase avidimab.

Front page of the guardian today. https://www.theguardian.com/society/2023/jul/07/skin-cancer-cases-reach-record-high-in-uk-with-sharp-rise-among-older-adults?CMP=Share_iOSApp_Other

Means the market for melanoma treatments is going to rise. SCIB1+ can be used to treat a broader amount of patients. Hopefully approval for this gets over the line soon. I know the HMRA is facing delays in approving studies and amendments. But hopefully this amendment to the SCOPE study will get over the line soon.